26-Aug-2014 - A US FDA reinspection of Alexion’s Rhode Island facility hit with a warning letter last year has resulted in a Form 483 with three observations.
26-Aug-2014 - Patheon has received approval from the DEA to bulk manufacture the schedule I product Gamma Hydroxybutyric Acid (GHB) from its facility in Cincinnati, Ohio.
26-Aug-2014 - EMD Millipore has been contracted to supply raw materials to the Samsung Biologics plant where ingredients for BM-S’ anticancer monoclonal antibody Yervoy (ipilimumab) are made.
26-Aug-2014 - Drug quality and standards organisation USP has joined a campaign to raise awareness about the risks posed by illegal online pharmacies.
25-Aug-2014 - Argentina decided to allow Indian drug imports after inspecting just five of the country's 793 manufacturing facilities according to documents released this week.
25-Aug-2014 - Our weekly round-up of the bright young things and big cheeses in pharmaceuticals.
25-Aug-2014 - Roche has bought InterMune for $8.3bn (€6.3bn) and says it will continue contracts with Catalent and two API suppliers for the manufacture of its lead product Esbriet (pirfenidone).
25-Aug-2014 - EFPIA (European Federation of Pharmaceutical Industries and Associations) and EGA (European Generics Association) have released comments suggesting specific changes to the EMA’s draft guidance on stability data for manufacturing changes.
22-Aug-2014 - GE Healthcare has said it plans to relocate operations in New Jersey to its new Massachusetts life sciences headquarters.
21-Aug-2014 - US FDA approval of the inhaled corticosteroid (ICS) asthma drug Arnuity will help offset declining sales of the off-patent bestseller Advair, says GlaxoSmithKline.
21-Aug-2014 - Indian manufacturer Claris Lifesciences has had its injectable drug manufacturing facility in Ahmedabad approved by the UK MHRA.
21-Aug-2014 - Ben Venue Laboratories will remain inactive says new owner Hikma as it looks to optimise its injectables manufacturing network.
21-Aug-2014 - Opiate API manufacturer Macfarlan Smith has been fined £12,000 for failing to ensure the safety of an employee injured at its plant in Scotland in 2011.
20-Aug-2014 - EU law changes mean all UK firms handling pharmaceuticals for export outside the EEA must now be inspected and pay license fees according to the MHRA.
20-Aug-2014 - Eisai has accused the US FDA of unlawfully shortening market exclusivity periods for Belviq and Fycompa by starting the countdown one year before either was scheduled by the DEA.
20-Aug-2014 - Nearly a month after India pushed back its deadline indefinitely for exporters to put bar codes on their primary packages, the Directorate General of Foreign Trade (DGFT) has set a new deadline of April 2015.
20-Aug-2014 - Indian drugmaker Amanta has received a warning letter after the US FDA found evidence of data falsification and unsanitary conditions – including dead and decaying frogs next to a product exit dock – during an inspection last year.
20-Aug-2014 - Novartis has invested $35m (€26.3m) for a 15% stake in Israel-based Gamida Cell, which offers stem cell expansion technologies and therapeutics.
19-Aug-2014 - WuXiPharmaTech has received US FDA approval to manufacture an API for a commercial drug from a plant in Shanghai.
19-Aug-2014 - For the first time ever, the US FDA has approved a needle-free injection system to deliver the seasonal flu vaccine.